Kornimate/medical-research-clean huggingface dataset:
mangoselect®: characterization, pharmacokinetics and bioavailability of xanthone metabolites

Conditions: Dietary Modification

Summary: the aim of this study is to compare pharmacokinetics and bioavailability of phenolic compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form or in an encapsulated form. absorption and metabolism will be determined by measuring urinary excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of high pressure liquid chromatography (hplc) coupled with tandem mass spectroscopy. the design of this study is a cross-over, double-blind and randomized trial on 10 healthy subjects.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent study * stated willingness to comply with all the study procedures and availability for the duration of the study * male and female * normal bmi range (18.50-24.99) * in good general health as evidenced by medical history * ability to take oral medication and be willing to adhere to lifestyle considerations exclusion criteria: * current use of any medication or food supplement * pregnancy or lactation * known allergic reaction to mangosteen * metabolic disorders or any kind of disease * currant smoker
the effect of ginger on the incidence of postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: this study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. half the patients were given an oral dose of ginger preoperatively and half received placebo.

postoperative nausea and vomiting (ponv) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. gynaecological surgery is considered high risk for ponv. ginger is a cheap, widely available and safe natural product in jamaica and has been found to reduce the incidence of nausea and vomiting in other clinical situations, such as in pregnancy. it is believed to act via the inhibition of serotonergic receptors.

Eligibility criteria:
inclusion criteria: * age 18 or above * undergoing elective intra-abdominal, gynaecological surgery exclusion criteria: * allergy to ginger, ginger by-products or cornstarch * gastroesophageal reflux disease (gerd) * allergy to any of the anaesthesia agents * inability to swallow capsules. * psychiatric illness which prevents patients giving informed consent. * psychological which prevents patients giving informed consent.

Keywords: postoperative nausea and vomiting ginger
microcirculation in cardiogenic shock

Conditions: Cardiogenic Shock

Summary: cardiogenic shock is usually defined as primary cardiac dysfunction with low cardiac output leading to critical organ hypo perfusion and tissue hypoxia. despite progress in the management of cardiogenic shock, mortality remains unacceptably high. this significant mortality, close to 40 %, is partly due to profound alterations of microcirculatory blood flow in cardiogenic shock, leading to multi organ failure, despite restoration of macro-hemodynamic parameters such as blood pressure and cardiac output. the microcirculation is the terminal vascular network of the systemic circulation consisting of microvessels with diameters \< 20 μm including arterioles, capillaries, and venules. this part of the circulation is critical as it is responsible for nutrient delivering and oxygen transfer from the erythrocytes in the capillaries to the parenchymal cells to meet their metabolic demands, but it is also the area where water, other gases, hormones and waste products are exchanged. hence, the evaluation of clinical signs of peripheral hypoperfusion reflecting microvascular perfusion is of interest. we aimed to study these parameters such as skin capillary refill time (crt), mottling and central-to-toe temperature difference (δtc-p) in a cardiogenic shock population. assessing the prognosis of these microcirculation parameters and their interaction with macrocirculation parameters such as arterial pressure, cardiac index, left ventricular ejection fraction is also the aim of this study. lastly, looking at the prognostic value of these markers seems interesting.


Eligibility criteria:
inclusion criteria: * major patient (≥18 years old) * patient with a cardiogenic shock table defined by the association of low cardiac output even though the filling pressures are normal or high, causing hypoperfusion and organ pain * patient affiliated to a social security scheme * patient (or family member / trusted or close) who has agreed to participate in the study exclusion criteria: * refusal of the patient to participate in the study * patients with dark skin preventing the evaluation of clinical markers of microcirculation. * subject under the protection of justice * subject under guardianship or curatorship
safety and efficacy of herbmed plus in patients withrenal calculi

Conditions: RENAL CALCULI

Summary: more specifically, the present invention relates to a 'herbal preparation' that is useful for * treatment of renal calculi * reduction in the stone size \& surface area * the expulsion of stone * decreased need of analgesic(antiinflammatory effect) * stops the recurrence and reformation of renal

1. study duration 28 weeks 2. no. of scheduled visits 8 visits 3. study product dose, group one-:1capsule (of 500 mg) orally twice a day with meals for 24 weeks. group two-:placebo1capsule (of 500 mg) orally twice a day with meals for 24 weeks.

Eligibility criteria:
inclusion criteria: * age 10-75 years (both inclusive) * patients with renal calculi, diagnosis confirmed by plain x-ray kub \&/or ultrasound kub/ct scan abdomen * size of the calculi ranging from 04 mm -09 mm * able and willing to give written informed consent and comply with the requirements of the study protocol * patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation * patients will to cooperate \& give consent for the trial\& comes for regular follow up. exclusion criteria: * patients having acute condition of renal calculi. * any systemic disease requiring other medications of surgery for calculus condition. * complicated cases of renal calculi requiring surgical condition. * chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction * any other urogenital disorders. * liver dysfunction, defined as total bilirubin more then 1.5 the upper limit of normal, aspartate aminotransferase more then 2.5 upper limit of normal, or alanine aminotransferase more then 2.5 upper limit of normal, * kidney disease, including serum creatinine level more then 1.5 upper limit of normal, * subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months. * participated in another clinical drug trial within 3 months before recruitment. * pregnancy or breast feeding * evidence of significant uncontrolled concomitant disease which in the investigator's opinion would preclude patient participation * currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline * patients with psychiatric illness or other condition that would limit compliance with study requirements * patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication * subjects who refuse to sign the informed consent document .

Keywords: renal calculi herbmed plus
once-daily asenapine for schizophrenia

Conditions: Schizophrenia

Summary: the investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder. the investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

the investigators will randomly assign 30 patients newly admitted to central regional hospital (crh) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to 14 days of treatment with either asenapine 5 mg bid or asenapine 10 mg qhs. the investigators will assess patient and staff acceptance on day 14. the investigators will assess staff acceptance on day 14. the investigators will assess changes in psychopathology (brief psychiatric rating scale) from baseline to day 14. the investigators propose to achieve the following specific aims: 1. to compare the patient acceptance of once daily versus twice daily asenapine; the investigators hypothesize that patient acceptance will be better for asenapine 10 mg qhs than for asenapine 5 mg bid at day 14 2. to compare the staff (medication nurses) acceptance of once daily versus twice daily asenapine; the investigators hypothesize that staff acceptance will be better for asenapine 10 mg qhs than for asenapine 5 mg bid at day 14 3. to compare the changes in psychopathology with once daily versus twice daily asenapine; the investigators hypothesize that changes in psychopathology from baseline to day 14 will be similar for the two dosing strategies

Eligibility criteria:
inclusion criteria: * male or female individuals, * 18-65 years of age, * who meet dsm-iv diagnostic criteria for schizophrenia or schizoaffective disorder, * who are newly admitted to central regional hospital for treatment of an acute psychotic exacerbation, * who provide signed informed consent to participate, will be included. exclusion criteria: * females who are lactating or pregnant, * individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded

Keywords: schizophrenia asenapine once daily twice daily
the relationship between physical activity and radiographic osteoarthritis worsening

Conditions: Osteoarthritis, Knee

Summary: wuchuan osteoarthritis study is a population-based longitudinal study of natural history of knee osteoarthritis and its risk factors. at baseline and follow-up visits, ipa-q questionnaire and a radiographs at tibiofemoral (tf) joints will be taken in order to assess the relationship between physical activity and radiographic osteoarthritis worsening.

1025 residents aged ≥ 50 years will be recruited using door-to-door enumeration in randomly selected rural communities in wuchuan, china, and will be followed in 3 years. at baseline and follow-up visits, subjects will complete a home interview (including, but not limited to, socio-demographic factors, physical activity level using ipa-q questionnaire,womac questionnaire) and have a weight-bearing posteroanterior semiflexed view of radiographs at tibiofemoral (tf) joints. radiographic osteoarthritis (roa) worsening for a knee is defined if its kellgren and lawrence (k/l) grade increases by at least 1 grade except for the change from 0 to 1 during follow-up. the relationship between level of physical activity and roa worsening will be assessed.

Eligibility criteria:
inclusion criteria: 1. people aged 50 or over 2. wuchuan permanent resident population exclusion criteria: 1. patients with rheumatoid arthritis 2. the disabled 3. patients with mental disorders 4. laid up for malignant tumor 5. people who live or work outside for more than half a year

Keywords: exercise physical activity radiographic osteoarthritis
observational study on safety of room temperature stable novoseven® in patients with haemophilia a or b

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this study is conducted in europe and asia. the aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of novoseven® (activated recombinant human factor vii).


Eligibility criteria:
inclusion criteria: * diagnosed with congenital haemophilia a or b with inhibitors to factor viii or factor ix * treated with room temperature stable novoseven®
a study in healthy volunteers to compare different tablet formulations of the test medicine, glpg1972, against the current tablet formulation, and to assess the effect food has on one of the test medicines

Conditions: Healthy

Summary: the sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). if one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. however, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.


Eligibility criteria:
inclusion criteria: * male between 18-55 years of age (extremes included), on the date of signing the informed consent form * a body mass index (bmi) between 18.0-30.0 kg/m2, inclusive * judged to be in good health by the investigator based upon the results of medical history, physical examination, vital signs, 12-lead ecg, and fasting clinical laboratory safety tests. clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator * subject must be able and willing to comply with restrictions on prior medication as described in the protocol * negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol exclusion criteria: * known hypersensitivity to imp ingredients or history of a significant allergic reaction to the investigational medicinal product (imp) ingredients as determined by the investigator, and/or known sensitivity to imp or the excipients (e.g. lactose). hay fever is allowed unless active. * positive serology for hepatitis b virus surface antigen or hepatitis c virus or history of hepatitis from any cause with the exception of hepatitis a that was resolved at least 3 months prior to first imp administration. * history of or a current immunosuppressive condition (e.g. human immunodeficiency virus infection) * having any illness, judged by the investigator as clinically significant, in the 3 months prior to first imp administration. * presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 ml/min, using the cockcroft-gault formula: if calculated result is ≤80 ml/min, a 24-hour urine collection can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
efficacy and mechanism of exenatide on improving heart function in type 2 diabetes with heart failure patients

Conditions: Type 2 Diabetes Mellitus; Heart Failure

Summary: the study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.

the study enrolls 234 patients with type 2 diabetes and heart failure. the patients have an new york heart association (nyha) functional class of ii to iv, are randomly assigned to 2 groups. one group use exenatide , the other group is control group and each group has 117 patients. at the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma n-terminal pro-b-type natriuretic peptide(nt-probnp), 6-min walking distance, echocardiographic measures, patient quality of life(mlhfq). at the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .

Eligibility criteria:
inclusion criteria: 1. diagnosed type 2 diabetes mellitus 2. hba1c 7%-10% and fasting plasma glucose(fbg) \<10mmol/l 3. age 18-65 years 4. nt-probnp level≥ 450 pg/ml 5. left ventricular ejection fraction (lvef)\<40% exclusion criteria: 1. uncorrected primary vascular disease 2. congenital heart disease 3. left ventricular outflow obstruction 4. myocarditis 5. aneurysm 6. uncontrolled severe arrhythmia 7. cardiogenic shock 8. unstable angina, or acute myocardial infarction 9. severe primary hepatic, renal, or hematologic disease 10. cr\>194.5 mmol/l or k+\>5.5 mmol/l 11. systolic blood pressure (sbp) ≥180mm hg or diastolic blood pressure (dbp) ≥110mm hg 12. alanine aminotransferase (alt) \>3 times the upper normal limit 13. patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks 14. patients had undergone or were likely to undergo cardiac resynchronization therapy 15. pregnant or lactating known 16. suspected to be allergic to the study drugs 17. use dipeptidyl peptidase-4 (dpp-4) or glucagon-like peptide-1 (glp-1) drug in 3 months 18. hyperthyroidism and hypothyroidism 19. tumor 20. received another investigational drug within 30 days prior to randomization 21. severe mental health condition or other uncontrolled systemic disease.
interferon-α after dli for the prevention of relapse

Conditions: Leukemia

Summary: this study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte infusion (dli) among high-risk acute leukemia patients undergone unmanipulated blood and marrow transplantation. hematopoietic stem cell transplantation (hsct) is an effective treatment option for high-risk acute leukemia (al). however, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.prophylactic dli can decrease the risk of relapse of high-risk al patients. interferon α-2b exerts a relatively strong immunomodulatory effect. it can kill al cells by regulating t-cell and/or natural killer cell functions.consequently, interferon α-2b may have potential value for high-risk al patients after transplantation. the study hypothesis: using interferon α-2b after prophylactic dli following hematopoietic stem cell transplantation in patients with high-risk al can further reduce relapse rate and improve leukemia-free survival.

high risk acute leukemia patients (except t(9;22)(q34; q11) cytogenetic abnormalities.) received interferon α-2b after prophylactic dli at day 30-60 after unmanipulated blood and marrow transplantation. the end points were safety, leukemia-free survival, and immunologic response. following time is 12 months.

Eligibility criteria:
inclusion criteria: * patients who had high-risk acute leukemia after hematopoietic stem cell transplantation exclusion criteria: * patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse

Keywords: interferon alfa-2b relapse donor lymphocyte infusion
β-d-glucan (bdg) surveillance with preemptive anidulafungin vs. standard care for invasive candidiasis in surgical intensive care unit (sicu) patients

Conditions: Invasive Candidiasis

Summary: this is a single center, prospective, open label assessment of β-d-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (sicu) patients. subjects will be stratified by apache ii score and randomized in 3:1 fashion to either biweekly surveillance using the β-d-glucan assay or standard care. subjects in the active monitoring arm will receive intravenous anidulafungin should the β-d-glucan exceed 60 pg/ml on a single determination. subjects in the standard care arm will have biweekly blood draws for β-d-glucan, but the specimens will be batched and tested retrospectively. antifungal use in the standard care arm is at the discretion of the treating physicians. the primary study end-points are the feasibility of a preemptive antifungal strategy in a sicu setting, β-d-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.


Eligibility criteria:
inclusion criteria: * age ≥18 years * admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours * iv access for administration of study drug * subject (or subject's legal representative) able to give written informed consent exclusion criteria: * history of hypersensitivity or intolerance to echinocandin antifungals * liver function test (alt, ast (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (uln) * pregnant or lactating women * treatment with systemic antifungal therapy within the preceding 7 days * documented invasive fungal infection at baseline/screening * life expectancy less than 2 days or moribund

Keywords: candidemia invasive candidiasis preemptive antifungal therapy surveillance β-d-glucan (bdg)
manual therapy vs stretching vs routine physical therapy in nonspecific chronic neck pain

Conditions: Neck Pain

Summary: the aim of this study is to analyze the effect of mulligan technique vs stretching techniques and vs routine physical therapy on pain ,range of motion(rom) and functional disability among restaurant chefs with non-specific chronic pain.

neck pain (np) is one of the basic musculoskeletal issues. neck pain can be due to stress about the musculoskeletal framework because of postural problems and may be related with different causes, such as: - intervertebral disc herniation, -nerve compression -fracture. nonspecific neck pain is a pain located in the lateral and posterior neck that does not show pathognomonic signs and symptoms. when the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity, being denominated non-specific chronic neck pain (ncnp). it is a common disorder, which generates a great impact and socio-economic cost . in this study we evaluate the comparison of manual physical therapy vs routine physical therapy vs stretching physical therapy effects among restaurants chefs having non-specific chronic pain.

Eligibility criteria:
inclusion criteria: * neck pain for atleast 3 months having no : * neurological problem * rheumatological problem * patient had taken any analgesic medication for neck pain for last 3 months. * non specific neck pain * age 18-60 years exclusion criteria: * neck pain due to, * tumors * ankylosings spondylitis * fracture * dislocation * presence of cord compression * vertebrobasilar artery insufficiency * osteoprosis or osteopenia * long term use of anticoagulant or corticosteroid drugs * pain due to any congenital deformity, inflammation or any infection * carcinoma

Keywords: neck pain manual therapy stretching exercises physical therapy